This diverse role may entail activities in Medical Affairs, Clinical Development, and Pharmacovigilance (PV) within a vast array of therapeutic areas and disease states. The Medical Consultant will team up with a Business Consultant and with a Medical Executive to support Bio/Pharmaceutical companies (the client) and help them meet their medical needs. This unique opportunity provides exposure to many areas and projects within the medical office, as well as, opportunity for increasing responsibility and career growth.
This role may be based in NJ, NY, MA, CO, or TX.
Potential areas of Responsibilities: Experience in as many areas as possible is desirable, however, expertise in limited areas with willingness to learn would be considered.
Sample activities (not all-inclusive)
Medical Affairs (MA):
Review, quality-check (QC), and approve of client scientific material (slides, videos, brochures, presentations) to ensure medical accuracy, comprehensiveness, and compliance
Supports client in development of company-wide medical training documents (slides, videos), as well as, any other client projects and needs
Work with client to create Scientific Communication Plans
Medical Strategy development
Work with Senior SSI Medical Executives to put together strategic roadmaps for medical affairs organizations
Able to help provide insights and draft plans for utilization of medical field force
Medical Information (MI)
Develop and QC MI letters using medical and scientific resources to support client department needs
Create and QC MI guidance documents to fulfill regional company needs
Develop frequently asked questions (FAQs) for health-care providers
Able to review and comment on Clinical Development plans from scientific and medical perspective
Draft clinical protocols with senior medical personnel
Understand and participate in CRO guidance activities
Participate in client internal meetings as a scientific contributor
Quality, Compliance and Pharmacovigilance (PV):
Contribute to Risk Management planning, support signal detection activities, and writing of aggregate safety reports (PSURs/DSURs) and Risk Management Plans (RMPs)
PV lead for clinical trials in various indications
Participate in and support client during Health Authority (HA) audits, assist with management of Corrective and Preventative Action Plans (CAPAs)
Able to draft SOPs across medical function from starting templates
Education and Experience Requirements
Advanced degree (i.e. PhD or PharmD) in a biosciences discipline required
3-5 years work experience in Medical Affairs, Clinical Development, or Pharmacovigilance in Bio/Pharma industry.
Experience within roles such as Medical Communications, Medical Operations, Medical Field (MSL, etc.), or Medical Information, is an asset.
Experience interacting with and managing vendors
Key Skills, Abilities, and Competencies
Excellent verbal and written communication skills. Able to present, discuss and communicate medical and scientific data
Strong analytical & problem-solving skills, able to integrate complex and large data sets into written communication
Strong scientific background, with a good understanding of clinical research and bioscience methodologies.
Strong team player with good interpersonal skills with team members at all levels
Awareness of the sensitive and confidential nature of information and situations
Ability to organize projects as well as to prioritize and cope with conflicting pressures
Understanding of pharmaceutical drug development and of scientific communication across the product life cycle
Good knowledge of pharmaceutical regulations in key markets
Knowledge of scientific platform development, publications, congresses and advisory boards desired
Ability to work independently, self-reliant, resourceful yet knows when to reach out for guidance, assistance, or clarification.
Focus on accountability and ownership.
Excellent collaboration skills and partnership to collaborate with the Business Consultants and clients.
Good project management skills are needed to deal with multiple tasks and working with multiple clients in an efficient way
Other Job Requirements
Availability to travel approximately 25% of the time
Availability to participate in early or late meetings occasionally
About SSI Strategy
SSI Strategy combines business acumen, medical and pharmacovigilance domain expertise, and operating experience to provide unparalleled support to our clients.
We work with companies ranging from emerging private companies to the largest global firms. Our staff of ex-Chief Medical Officers and former Heads of Medical Affairs and Safety will work to ensure the right balance of medical and business focus by understanding drivers for the firm and rolling up our sleeves to get work done.
Our team members work closely together with our client's teams to understand their business and medical challenges in order to help transform them into a high impact medical organization.
Our teams consist of seasoned consultants, former Chief Medical Officers, and other Subject Matter or Therapeutic Area Experts, each of which bring their unique expertise to build meaningful solutions for our clients. We have found that this model brings the best of both the business and medical world together, and ensures our solutions make business and medical sense.